FDA Conference on Regulatory Education for Industry is Next Week

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

The United States Food and Drug Administration (FDA) is hosting its annual conference, Regulatory Education for Industry (REdI), virtually next week from July 19-23. Register for this free conference to learn directly from senior leadership at FDA. Continuing education credits for several professional organizations are available, and this conference can also be used toward GxP training now required by the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards.

For the first time, this conference will have tracks for three medical products: drugs, devices, and biologics. The biologics track will focus on different aspects of product development of advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER). Topics include regulation of tissue products under 21 CFR part 1271; development and regulation of cellular, gene, and plasma-derived therapies, and expedited programs for advanced therapies.

Register for the free, virtual FDA REdI Conference


Navigating the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Webinar

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

The eighth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar, titled Navigate the Eighth Edition Cellular Therapy Standards, on July 21, 2021 at 10 am CT, 3 pm GMT. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including:

 

  • Genetically-modified cellular therapy products
  • Training in GxP
  • Quality management
  • Informed consent
  • Labeling
  • Storage

 

 


Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021


FACT Cord Blood Educational Events Announced

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

Join FACT for a cord blood inspection and accreditation workshop and quality boot camp on Wednesday, September 29, 2021, from 7:00 am – 4:00 pm CT, 12:00 – 21:00 GMT. The FACT workshop morning sessions will begin with an overview of FACT accreditation, detailing the accreditation process from application to accreditation. Sessions continue with a guided tour of a cord blood bank in which the presenter will review requirements in the FACT Cord Blood Banking Standards that can be identified and evaluated during the tour (on-site or virtual).  Next, presenters will discuss common citations in cord blood banking and how to avoid them. Examples will be provided, and case studies presented.  Finally, the morning workshop will end with short presentations from cord blood banks with different organizational models including public, private, and hybrid, who will discuss maintaining operations and compliance through various cord blood banking challenges.  Afterwards, participants can ask questions to an expert panel.

The afternoon quality boot camp sessions begin with a presentation on developing a Quality Management Plan and assessing its effectiveness.  The presentation will be followed by a question and answer session and an interactive break-out session. The second half of the afternoon will focus on stability studies in cord blood banking and includes a presentation on the results of the AABB/ISCT stability studies survey, presentations on establishing and maintaining a stability program within a public or private cord blood bank, and ends with a panel discussion.

During lunch, attend an optional featured session! Listen to FACT’s new president, Dr. Catherine Bollard, reflect on the accomplishments and the future of FACT.

Register now for early bird pricing!

FACT workshop and quality boot camp hosts:

Roger Horton, PhD
Cord Blood Bank Director
The Anthony Nolan Cord Blood Bank
Diane Fournier, PhD
Laboratory Head and Scientific Director
Héma-Québec Cord Blood Bank

ASTCT Fundamentals of HCT Training Course Takes Place This Weekend – Registration is Still Open! Course Can be Applied Toward FACT Requirements for Continuing Education

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

FACT encourages you to take advantage of the ASTCT Fundamentals of HCT Training Course. Hosted by one of our parent organizations, this course can be applied toward FACT requirements for continuing education.

The Fundamentals of HCT Training Course is a two-day conference that will be taking place virtually on Saturday, April 24 – Sunday, April 25. This course provides a broad overview and introduction of hematopoietic cell transplantation (HCT), also referred to as blood and marrow transplantation (BMT), as well as cellular immunotherapy (CI). Throughout the lectures, participants will be introduced to numerous aspects of the HCT-CI processes, which are designed to develop or enhance skills required in the management of patients undergoing these procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on the pharmacotherapeutic management. Additional details, guidance, and review of clinical materials can also be found in the supplemental electronic handbook. The target audience for this course includes new practitioners, residents, fellows, pharmacists, and nurses or those training in this discipline.

Registration to the virtual conference includes access to the newly revised Fundamentals of HCT eBook. The Fundamentals of HCT eBook provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. This is a great resource!

Registration will close at 4PM CT on Friday, April 23.

Register for the ASTCT Fundamentals of HCT Training Course


Register for the Upcoming Inspection and Accreditation Virtual Workshop on May 6, 2021

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

Join FACT for an inspection and accreditation virtual workshop on Thursday, May 6, from 7:30 am – 5:15 pm CT, 12:30-22:15 GMT. The FACT workshop is intended for apheresis and processing personnel, and serves as the opening act to the May scientific annual meeting headliners, The American Society for Apheresis (ASFA) and The International Society of Cell and Gene Therapy (ISCT). Separate registration is required. 

The FACT workshop morning sessions will interest initial apheresis and processing applicants and those who have limited experience with FACT accreditation.  The afternoon features more advanced content and is designed for those who have attended previously. We encourage all participants to stay for the entire day; however, all sessions will be available on-demand after the workshop for 30 days.  Registrants will have access to both tracks’ on-demand sessions.

Morning sessions include:

  • An overview of FACT Accreditation
  • A review of the compliance application process
  • How to prepare for an inspection
  • A virtual tour of an accredited apheresis and processing program
  • Common challenges apheresis and processing programs encounter and how to correct the deficiencies

Advanced sessions include:

  • How to prepare for a FACT virtual inspection
  • Navigating the Eight Edition Cellular Therapy Standards
  • Maintaining Chain of Identity and Chain of Custody
  • Panel Discussion:  Get your questions from the day answered by the experts!

During lunch, attend optional featured sessions! Listen to FACT’s new president, Dr. Catherine Bollard, reflect on the accomplishments and the future of FACT.  Also, hear from leaders of the Baylor College of Medicine Stem Cell Transplant Program regarding their experience as one of FACT’s first virtual inspection programs.  Learn what worked well, challenges faced by program personnel, and suggestions moving forward.

Register for the workshop

Register for the ASFA Annual Meeting

Register for the ISCT Annual Meeting


FACT Quality Boot Camp in partnership with ASFA and ISCT to Discuss Navigating a Changing Environment Using Quality Systems – Register Today!

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The next FACT Quality Boot Camp, in partnership with ASFA and ISCT, will take place on May 21, 2021. Discuss and explore core quality concepts throughout the day and learn how to apply those concepts during interactive sessions focused on apheresis and processing. These sessions will provide attendees the opportunity to discuss issues, ask questions, apply concepts learned, and navigate components of the quality system from beginning to end, including:

  • Change Control
  • Risk Assessments
  • Tracking and Tracing
  • Validations/Audits
  • Unexpected Outcomes and Events
  • Corrective Action and Preventive Actions

The intended audience is apheresis and processing personnel. At the end of the day, boot camp participants will be able to apply learned concepts to their own programs’ needs.

Register for the Boot Camp

Register for the ASFA Annual Meeting

Register for the ISCT Annual Meeting


FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Draw Record Attendance

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

The second month of 2021 brought success by way of greatly increased access to FACT’s education for an expanded online audience. FACT held its second virtual Inspection & Accreditation Workshop on February 4th and first virtual FACT-ASTCT Quality Boot Camp on February 5th. Though the pandemic prevented the conference from taking place in Hawaii during the TCT meetings, it could not stop the cellular therapy community from catching up with dearly missed colleagues over virtual coffee and continuing to advance their programs via e-learning. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp.

We send a huge thank you to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.

FACT Inspection & Accreditation Virtual Workshop – February 4, 2021

The workshop day was divided into morning and afternoon sessions. The morning catered to individuals new to or relatively inexperienced with FACT Standards and the accreditation process. The sessions included:

  • An overview of FACT Accreditation
  • A review of the compliance application process
  • How to prepare for an inspection
  • A virtual tour of an accredited clinical program
  • Common challenges clinical programs encounter & how to correct the deficiencies
  • How to maintain FACT Accreditation

The afternoon was prepared with more advanced content for attendees that had previously attended a workshop and were more familiar with FACT Accreditation. The sessions included:

  • How to prepare for a FACT virtual inspection
  • A sneak peek at the Eighth Edition for Cellular Therapy Standards
  • Data management
  • Outcome analysis

     

 FACT-ASTCT Quality Boot Camp – February 5, 2021

The boot camp focused on a holistic approach to the quality system by featuring core quality concepts in the presentations and interactive sessions. The boot camp showed attendees how to navigate the quality system from start to finish. The sessions included:

  • What to consider for performing a feasibility needs assessment from a new IEC program perspective
  • An overview of the change control process and its development for new or changing services
  • How to execute the risk assessment process and plan with help from a matrix table
  • Reviewing what to validate and how the validation process works
  • How to establish quality indicators
  • An overview of auditing in terms of what, when, and how
  • Interactive discussions to reinforce the concepts of change control, risk assessment, validation, and audits

       

Both the workshop and the boot camp included optional sessions at lunch. The first session was an interview with Dr. Nelson Hamerschlak and Dr. Andrea Kondo from the Hospital Israelita Albert Einstein in São Paulo, Brazil. The transplant program leaders discuss how FACT Accreditation has benefited their program and prepared them to safely manage patients during the COVID-19 pandemic. The second session was a speech from incoming FACT President, Catherine Bollard, about her vision for FACT as we move forward. (Click on the images below to watch the videos free of charge!) Jeopardy was a popular segment in both conferences as participants enjoyed reinforcing concepts discussed throughout the day in a fun and interactive method.

The end of the day closed with a third optional session led by FACT IT Business Analyst, Alisa Forsythe, during which she trained accredited users on the FACT Portal.

Click on the images to watch the videos free of charge!

We look forward to FACT’s next Processing and Apheresis Accreditation & Inspection Workshop and Quality Boot Camp on Thursday, May 6 and Friday, May 7, 2021!

 


Save the Date! FACT Announces the Apheresis and Processing Accreditation & Inspection Workshop and Quality Boot Camp on May 6-7, 2021

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021


Upcoming Events

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


FACT Announces Upcoming Virtual Events

Posted in :: 2020 Volume 9 :: Monday, December 14th, 2020

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


View the FACT Virtual Workshop that Everyone is Talking About

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

As reported in a previous newsletter article, the first FACT Inspection & Accreditation Virtual Workshop on September 21, 2020 was well received by those in attendance, and we are pleased to provide everyone with an opportunity to view the recording of the workshop.

The workshop began with an overview of the FACT accreditation process and continued with hands-on activities to guide the applicant through the accreditation process. Workshop objectives include:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

A digital download of the workshop recording can be purchased from the FACT online store at competitive prices. As always, inspectors and inspector trainees may download the recording for free!

Purchase the virtual workshop recording


FACT-SBTMO Accreditation Virtual Workshop for Transplant Programs in Brazil

Posted in :: 2020 Volume 9 :: Monday, December 7th, 2020

The second edition of the FACT-SBTMO Accreditation Workshop for transplant centers in Brazil occurred during an online event on October 27, 2020. The pre-conference event took place prior to the SBTMO 2020 Congress and was simulcast in both Portuguese and English. The virtual platform enabled program personnel throughout Brazil to participate in the workshop. Interactive sessions provided an overview of FACT Cellular Therapy Standards, emphasized the importance of a quality management program including document control and validation, and addressed areas that are challenging for new centers. Members from Hospital Israelita Albert Einstein, the first FACT-accredited program in Brazil, shared their experience in organizing and preparing for a successful inspection and accreditation process. Nearly 40 transplant centers in Brazil have expressed their interest and commitment to improving quality and safety through the FACT-SBTMO accreditation program.


FACT-SBTMO workshop presenters enjoy interacting with workshop participants. Pictured from top to bottom are Andrea Kondo, Carlos Bachier, Carlos Ramos, Phyllis Warkentin, and Daniel Kota.


FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.

Presenters include:

  • Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
  • Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)

FACT also encourages you to join the Save the Cord Foundation on November 17 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 16:

  1. Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Meeting ID: 922 6984 5238
  3. Passcode: WCBD

_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:

  • Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
  • Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)

FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.

Instructions pour rejoindre le webinaire le 16 Novembre:

  1. Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Identification de la conférence: 922 6984 5238
  3. Mot de passe: WCBD

FACT Inspection & Accreditation Virtual Workshop an Interactive and Educational Success

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT’s first Inspection & Accreditation Virtual Workshop, hosted on September 21, 2020, was a great success! FACT thanks the workshop chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH; the FACT Education Committee, the presenters, and the attendees for bringing energy and enthusiasm to this important educational event. A culture of quality is as important now as it ever was, and we enjoyed being “with” the FACT community again!

Please Complete the Workshop Evaluation

If you attended the workshop, please tell us everything! We are always striving to provide a great educational experience.  As part of this, we would appreciate feedback on FACT’s first virtual workshop so we can improve and make the next virtual event even better.

Complete virtual workshop evaluation

Summary

Workshop Registrants

The Foundation for the Accreditation of Cellular Therapy hosted its first virtual inspection and accreditation workshop on September 21, 2020.  The workshop included two tracks, apheresis collection and cord blood banking. Attendance included 165 workshop registrants, 35 FACT staff members and Matrix Maxx staff members, and 19 workshop presenters and moderators. The breakdown of the 165 attendees is illustrated below:

Registrants from 18 different countries attended, including:

Lunch with Leaders

Participants were able to ask any question to FACT leaders during the Lunch with Leaders session.

Favorite Parts of the Day

In addition to these favorite parts of the day, attendees enjoyed feeling connected with the international FACT community during this challenging year and felt the workshop was one of the most interactive and engaging virtual conferences. Attendees also felt that the workshop was comprehensive and educational despite being virtual.

Workshop Programming

The workshop included pre-recorded presentations, live question and answer sessions, interactive activities requiring audience participation, and a live tour of an apheresis unit and cord blood bank.

Participants were able to ask questions at any time via the workshop chat feature.  Each track included a moderator; Dr. Dennis Gastineau moderated the apheresis track and Dr. Kim Kasow moderated the cord blood track.   Dr. Gastineau and Dr. Kasow were able to monitor presentation chat questions and interact with the presenters to ensure all questions were answered.

Participants joined in polling sessions, which allowed them to participate in analyzing case studies on both workshop tracks.


Calling All Cord Blood Banking Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all cord blood banking professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!


Calling All Apheresis Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all apheresis professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!